Clinical trial

Glucagon-Like Peptide-1 Receptor Agonist in ADPKD

Recruiting now · Phase 2 · 1 countries · Registry ID NCT06582875

Recruiting nowPhase 2Interventional

What this study is about

The proposed clinical trial aims to assess if a year of treatment with a glucagon-like peptide 1 receptor agonist, a medication approved for weight management that also improves the body's response to glucose and insulin, can slow kidney growth in adults with autosomal dominant polycystic kidney disease who are overweight or obese. The study will also evaluate changes in abdominal fat and kidney metabolism using cutting-edge images techniques. Blood and urine samples will provide further insight into biological changes that may be linked to the benefits of the intervention, while ensuring careful monitoring of safety and tolerability.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionAutosomal Dominant Polycystic Kidney, Obesity

Full registry criteria

Inclusion Criteria: * 18-65 years of age * ADPKD diagnosis based on the modified Pei-Ravine criteria * Body-mass index of ≥27 kg/m\^2 * Estimated glomerular filtration rate ≥ 30 mL/min/1.73m\^2 * Mayo Classification of C, D, or E, calculated from a previous kidney ultrasound or MRI performed within the last 12 months * Not currently participating in or planning to participate in any formal weight loss or physical activity program, or another interventional study * Ability to provide informed consent Exclusion Criteria: * Diabetes mellitus * Tolvaptan usage or plans to initiate tolvaptan * History of hospitalization or major surgery within the last 3 months * Uncontrolled hypertension (systolic blood pressure \> 160 or diastolic blood pressure \>100 mm Hg) * Pregnancy, lactation, or unwillingness to use adequate birth control * Regular use of prescription or over-the-counter medications that may affect weight, appetite, food intake, or energy metabolism * History of clinically diagnosed eating disorder including: anorexia nervosa, bulimia, binge eating disorder * Weight change of \>5% in the past 3 months for any reason except post-partum weight loss * Inability to cooperate with or clinical contraindication for MRI including: severe claustrophobia, implants, devices, or non-removable body piercings * Presence or personal history of malignant neoplasm within 5 years prior to the day of screening * Personal or family history of medullary thyroid carcinoma, thyroid nodule, or multiple endocrine neoplasia type 2 * Prior history of pancreatitis * Weight ≥450 lb

Treatments and study arms

Tirzepatide

Drug

Titrated to dose of 5 mg once weekly subcutaneous

Placebo

Other

Titrated to dose of 5 mg once weekly subcutaneous

Primary outcomes

Change in height-Adjusted Total kidney volumeBaseline, 12-months

To assess kidney growth,height-adjusted total kidney volume will be measured by magnetic resonance imaging at baseline and 12 months to determine annual percent change.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Colorado - Anschutz Medical Campus🇺🇸 Aurora, Colorado, United States
Kristen Nowak, PhD, MPHContact
Kristen Nowak, PhD, MPHPrincipal Investigator